combination chemotherapy in treating children with relapsed acute lymphocytic leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. purpose: phase ii/iii trial to study the effectiveness of combination chemotherapy in treating children with relapsed acute lymphocytic leukemia.

objectives: i. evaluate the feasibility, at gatla, of a study of the treatment of all in first hematologic relapse following treatment on a bfm protocol. ii. evaluate the efficacy of induction with vincristine/daunorubicin/asparaginase/prednisone in producing a second complete remission in these patients, and evaluate the toxicity of this regimen. iii. evaluate the efficacy and toxicity of the capizzi i regimen (vincristine/asparaginase/methotrexate) and capizzi ii regimen (cytarabine/asparaginase/daunorubicin) when given to maintain and prolong complete remission. iv. offer the option of bone marrow transplantation to those patients who are in second remission and who have a histocompatible donor, and compare outcome of these patients with those on chemotherapy alone. outline: nonrandomized study. patients achieving remission on induction proceed to interim maintenance, then to continued maintenance; those failing to achieve remission receive salvage re-induction, followed, if remission is achieved, by interim maintenance, then continued maintenance. induction: 4-drug combination chemotherapy with cns prophylaxis/therapy. vincristine, vcr, nsc-67574; prednisone, pred, nsc-10023; asparaginase, asp, nsc-109229; daunorubicin, dnr, nsc-82151; with intrathecal cytarabine, it ara-c, nsc-63878; intrathecal dexamethasone, it dm, nsc-34521. interim maintenance: 3-drug combination chemotherapy with, as indicated, radiotherapy. vcr; asp; methotrexate, mtx, nsc-740; with, as indicated, testicular irradiation (equipment not specified). continued maintenance: 3-drug combination chemotherapy followed by 3-drug combination chemotherapy with cns prophylaxis and, as indicated, radiotherapy. capizzi ii: ara-c; asp; dnr; followed by capizzi i: vcr; asp; mtx; with it ara-c; it dm; and, as indicated, cranial irradiation (equipment not specified). salvage re-induction: 2-drug combination chemotherapy. ara-c; asp. projected accrual: at least 72 evaluable patients will be entered. accrual is expected to be completed in 3 years.

Eligibility criteria:
disease characteristics: all in first hematologic relapse during or following completion of treatment on a bfm protocol (arg-gatla-1-lla-82, -84, -87, or -90) m2-m3 bone marrow required patient characteristics: age: under 20 performance status: not specified life expectancy: greater than 8 weeks hematopoietic: not specified hepatic: no significant liver disease renal: no significant kidney disease cardiovascular: no significant heart disease pulmonary: no significant lung disease other: no significant digestive disease prior concurrent therapy: biologic therapy: not specified chemotherapy: prior total anthracycline no greater than 280 mg/sqm endocrine therapy: not specified radiotherapy: not specified surgery: not applicable

Keywords: recurrent childhood acute lymphoblastic leukemia